Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP

• Registration Number: NCT02894944
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is assessed in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Primary Completion: 2018-11
• Study Completion: 2019-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients with pancreatic cancer stage 3
• Patients with histologically confirmed pancreatic adenocarcinoma
• Patients with no evidence of peritoneal or hematogenous metastasis
• Patients with ECOG performance status 0-2
• Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
• Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL)
• Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 2.5 times upper limit of normal (ULN))
• Patients with agreement with informed consent
• Male patients with contraception

Exclusion Criteria

• Female patients with childbearing age or pregnancy or breast feeding
• Patients with a history of chemotherapy within 5 years
• Patients with a history of radiation on more than 25% of bone marrow
• Patients with unknown stage or recurrent pancreatic cancer
• Patients with a history of skin cancer except malignant melanoma or malignancy except stage 0 cervical cancer
• Patients with a history of major surgery except laparoscopic exam, endoscopic ultrasound, stenting, or PEG/PEJ placement
• Patients with active or uncontrolled infection
• Patients with immunosuppression or susceptibility to viral infection
• Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
• Patients with a history of allergy to clinical trial medications
• Patients who are considered as inappropriate candidate by investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Theragene arm	Theragene®,Ad5-yCD/mutTKSR39rep-ADP	Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events assessed by CTCAE v4.03	8 weeks

Secondary Outcome Measures

Name	Time	Method
Detection of Infected Adenovirus in blood and urine assessed by PCR	8 weeks
Detection of adenoviral DNA in blood by PCR	8 weeks
Number of participants with treatment-related adverse events assessed by CTCAE v4.03	12 weeks
Tumor response	8 weeks
Time to disease progression	6.5 months

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of